Olmesartan/hydrochlorothiazide Combix 20 mg/25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Olmesartan/Hydrochlorothiazide Combix 20 mg/25 mg film-coated tablets EFG

Olmesartan medoxomil/hydrochlorothiazide

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Olmesartan/Hydrochlorothiazide Combix is and what it is used for
2. What you need to know before taking Olmesartan/Hydrochlorothiazide Combix
3. How to take Olmesartan/Hydrochlorothiazide Combix
4. Possible side effects
5. How to store Olmesartan/Hydrochlorothiazide Combix

Pack contents and additional information

1. What Olmesartán/Hidroclorotiazida Combix is and what it is used for

Olmesartán/Hidroclorotiazida Combix contains two active substances, olmesartán medoxomilo and hidroclorotiazida, which are used in the treatment of high blood pressure (hypertension):

• Olmesartán medoxomilo belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.

• Hidroclorotiazida belongs to a group of medicines called thiazide diuretics. It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

You will only be given Olmesartán/Hidroclorotiazida Combix if treatment with olmesartán medoxomilo alone has not adequately controlled your blood pressure. The combined administration of both active substances in Olmesartán/Hidroclorotiazida Combix contributes to a greater reduction in blood pressure than when each substance is administered alone.

You may already be taking medicines to treat high blood pressure, but your doctor may consider it necessary for you to take Olmesartán/Hidroclorotiazida Combix to lower it further.

High blood pressure can be controlled with medications such as Olmesartán/Hidroclorotiazida tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol consumption, and reducing salt intake). Your doctor may also have recommended that you exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you need to know before taking Olmesartan/Hydrochlorothiazide Combix

Do not take Olmesartan/Hydrochlorothiazide Combix

• if you are allergic to olmesartan medoxomil, hydrochlorothiazide, any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
• if you are more than 3 months pregnant. (It is also advisable to avoid Olmesartan/Hydrochlorothiazide at the beginning of pregnancy – see Pregnancy section).
• if you have kidney problems.
• if you have low levels of potassium or sodium in the blood, high levels of calcium or uric acid in the blood (with symptoms of gout or kidney stones) that do not improve with treatment.
• if you have moderate or severe liver problems, yellowing of the skin or eyes (jaundice), or problems with bile drainage from the gallbladder (biliary obstruction, e.g., due to gallstones).
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these situations apply to you, or are unsure, do not take the tablets. Speak to your doctor and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Olmesartan/Hydrochlorothiazide Combix:

If you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren

If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within a few hours to one week after taking Olmesartan/Hydrochlorothiazide Combix.

If you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Olmesartan/Hydrochlorothiazide Combix.

If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Olmesartan/Hydrochlorothiazide, contact your doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking olmesartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking olmesartan/hydrochlorothiazide monotherapy without medical advice.

See also the information under the heading “Do not take Olmesartan/Hydrochlorothiazide Combix”.

Before taking the tablets, tell your doctor if you have any of the following health conditions:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Vomiting (with dizziness) or diarrhea that is severe or lasts for several days.
• Treatment with high doses of medicines that increase urine elimination (diuretics), or if you are on a low-salt diet.
• Problems with adrenal glands (e.g., primary hyperaldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergy or asthma.

Contact your doctor if you develop severe, persistent diarrhea causing significant weight loss. Your doctor will evaluate your symptoms and decide how to continue your blood pressure treatment.

Your doctor may want to see you more often and carry out some tests if you have any of these conditions.

Olmesartan/Hydrochlorothiazide may increase blood levels of lipids and uric acid (which can cause gout – painful joint swelling). Your doctor may want to carry out blood tests from time to time to monitor these possible changes.

Changes in blood levels of certain chemicals called electrolytes may occur. Your doctor may want to carry out blood tests periodically to monitor this possible effect. Some signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, tired muscles, low blood pressure (hypotension), feeling weak, sluggish, tired, drowsy, restless, vomiting, reduced need to urinate, rapid heartbeat. Tell your doctor if you notice any of these symptoms.

As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.

If you are scheduled for tests of parathyroid function, you must stop taking Olmesartan/Hydrochlorothiazide before the tests are performed.

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

Inform your doctor if you are pregnant or think you might be pregnant. Use of Olmesartan/Hydrochlorothiazide is not recommended at the beginning of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken during this stage (see Pregnancy section).

Children and adolescents

Olmesartan/Hydrochlorothiazide is not recommended for children and adolescents under 18 years of age.

Taking Olmesartan/Hydrochlorothiazide Combix with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Olmesartan/Hydrochlorothiazide Combix” and “Warnings and precautions”).

In particular, inform your doctor or pharmacist about any of the following medicines:

• Medicines that may alter potassium levels in the blood when used together with Olmesartan/Hydrochlorothiazide. These include:
• Potassium supplements (as well as salt substitutes containing potassium).
• Medicines that increase urine elimination (diuretics).
• Heparin (a blood thinner).
• Laxatives.
• Steroids.
• Adrenocorticotropic hormone (ACTH).
• Carbenoxolone (a medicine used to treat mouth and stomach ulcers).
• Sodium penicillin G (an antibiotic also known as sodium benzylpenicillin).
• Some painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood disorders and certain types of depression) may have increased toxicity when used together with Olmesartan/Hydrochlorothiazide. If you need to take lithium, your doctor will monitor lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), when used together with Olmesartan/Hydrochlorothiazide, may increase the risk of kidney failure and reduce the effect of Olmesartan/Hydrochlorothiazide.
• Other blood pressure-lowering medicines (antihypertensives), as they may enhance the effect of Olmesartan/Hydrochlorothiazide.
• Sleeping pills, sedatives, and antidepressants, which when used with Olmesartan/Hydrochlorothiazide may cause a sudden drop in blood pressure upon standing.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Amifostine and other medicines used in cancer treatment, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower blood fat levels.
• Anticholinergic medicines such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.
• Oral antidiabetic medicines such as metformin, or insulin, used to lower blood sugar levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, since Olmesartan/Hydrochlorothiazide may intensify the blood sugar-raising effect of these medicines.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and reduce heart rate.
• Difemethiazene, used to treat slow heartbeat or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone, and allopurinol, used in the treatment of gout.
• Calcium supplements.
• Amantadine, an antiviral medicine.
• Cyclosporine, a medicine used to prevent organ transplant rejection.
• Antibiotics from the tetracycline group or sparofloxacin.
• Amphotericin, a medicine used to treat fungal infections.
• Some antacids used to treat excess stomach acid, such as aluminium and magnesium hydroxide, which may slightly reduce the effect of Olmesartan/Hydrochlorothiazide.
• Cisapride, used to increase stomach and intestinal motility.
• Halofantrine, used for malaria.

Taking Olmesartan/Hydrochlorothiazide Combix with food, drinks, and alcohol

Olmesartan/Hydrochlorothiazide may be taken with or without food.

Be cautious when drinking alcohol while taking Olmesartan/Hydrochlorothiazide, as some people may feel weak or dizzy. If this occurs, avoid alcohol, including wine, beer, or alcoholic soft drinks.

Patients of Black race

As with other similar medicines, the blood pressure-lowering effect of Olmesartan/Hydrochlorothiazide is somewhat reduced in patients of Black race.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to stop taking Olmesartan/Hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of Olmesartan/Hydrochlorothiazide is not recommended during pregnancy, and it must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Olmesartan/Hydrochlorothiazide is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Use in athletes

Athletes should be aware that this medicine contains a component (hydrochlorothiazide) that may result in a positive doping test.

Driving and use of machines

You may feel drowsy or dizzy while being treated for high blood pressure. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.

Olmesartan/Hydrochlorothiazide Combix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Olmesartán/Hidroclorotiazida Combix

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Recommended dose: 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/12.5 mg once daily. If blood pressure is not adequately controlled, your doctor may change the dose to 1 tablet of Olmesartán/Hidroclorotiazida 40 mg/25 mg once daily.

Take the tablets with water. If possible, take your dose at the same time each day, for example, with breakfast. It is important that you continue taking Olmesartán/Hidroclorotiazida unless your doctor tells you otherwise.

If you take more Olmesartán/Hidroclorotiazida Combix than you should

If you take more tablets than you should, or if a child accidentally swallows one or more tablets, contact your doctor immediately or go to the nearest hospital emergency department, and take the medicine package with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Olmesartán/Hidroclorotiazida Combix

If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Olmesartán/Hidroclorotiazida Combix

It is important to continue taking Olmesartán/Hidroclorotiazida unless your doctor tells you to stop.

If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience them.

However, the following adverse effects may be serious:

• In rare cases, allergic reactions affecting the whole body may occur, with swelling of the face, mouth and/or larynx, together with itching and skin rash. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide and consult your doctor immediately.
• Olmesartan/Hydrochlorothiazide may cause a marked drop in blood pressure in susceptible patients or as a result of an allergic reaction. Fainting or dizziness may occur infrequently. If this happens to you, stop taking Olmesartan/Hydrochlorothiazide, consult your doctor immediately and remain lying down in a horizontal position.
• Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have just started treatment with Olmesartan/Hydrochlorothiazide, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your blood pressure treatment.

Olmesartan/Hydrochlorothiazide is a combination of two active substances. The following information first describes the adverse effects reported so far with the combination Olmesartan/Hydrochlorothiazide (in addition to those already mentioned), and secondly, the known adverse effects of each of the two active substances taken separately.

These are other known adverse effects reported so far with Olmesartan/Hydrochlorothiazide:

If these effects occur, they are often mild and you do not need to stop treatment.

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon adverse effects (may affect up to 1 in 100 people):

Fast or strong heartbeat (palpitations), rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.

Uncommonly, some changes in blood test results have also been observed, including:

Increased levels of fat in blood, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood sugar, increased liver function test values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):

Feeling unwell, disturbances in consciousness, skin swelling (hives), acute kidney failure.

Rarely, some changes in blood test results have also been observed, including:

Increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will monitor you with a blood test and will advise you whether any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan/Hydrochlorothiazide or at a higher frequency:

Olmesartan medoxomil:

Frequent adverse effects (may affect up to 1 in 10 people):

Bronchitis, cough, nasal congestion and discharge, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, flu-like symptoms, pain.

Frequently, some changes in blood test results have also been observed, including:

Increased levels of fat in blood, increased blood urea or uric acid, increased liver or muscle function test values.

Uncommon adverse effects (may affect up to 1 in 100 people):

Rapid allergic reactions affecting the whole body, which may cause breathing difficulties and a rapid drop in blood pressure that may even lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rash, itching, exanthema (skin eruption), skin swelling (hives).

Uncommonly, some changes in blood test results have also been observed, including:

Reduction in the number of a type of blood cells called platelets (thrombocytopenia).

Rare adverse effects (may affect up to 1 in 1,000 people):

Worsening of kidney function, lack of energy.

Rarely, some changes in blood test results have also been observed, including:

Increased blood potassium levels.

Intestinal angioedema: swelling in the intestine causing symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Hydrochlorothiazide:

Very frequent adverse effects (may affect more than 1 in 10 people):

Changes in blood tests including: increased blood fat levels and increased uric acid levels.

Frequent adverse effects (may affect up to 1 in 10 people):

Feeling confused, abdominal pain, stomach discomfort, bloated feeling, diarrhoea, nausea, vomiting, constipation, glucose in urine.

Some changes in blood test results have also been observed, including:

Increased levels of creatinine, urea, calcium and blood sugar, decreased levels of chloride, potassium, magnesium and sodium in blood. Increased serum amylase (hyperamylasemia).

Uncommon adverse effects (may affect up to 1 in 100 people):

Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purple spots or patches on the skin due to minor bleeding (purpura), skin swelling (hives).

Rare adverse effects (may affect up to 1 in 1,000 people):

Inflammation and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in blood, anaemia, bone marrow depression, restlessness, depression, sleep problems, feeling of loss of interest (apathy), tingling and numbness, seizures, yellowish perception of objects when looking at them, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain and coldness in hands and fingers, skin allergic reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which sometimes causes movement disorders).

Very rare adverse effects (may affect up to 1 in 10,000 people):

Electrolyte imbalance which may cause abnormally low chloride levels in blood (hypochloremic alkalosis), intestinal obstruction (paralytic ileus), acute breathing difficulty (signs include severe shortness of breath, fever, weakness and confusion).

Frequency not known:

Skin and lip cancer (non-melanoma skin cancer), decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olmesartan/Hydrochlorothiazide Combix

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and on the blister after “EXP.”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olmesartan/Hydrochlorothiazide Combix

• The active substances are olmesartan medoxomilo and hydrochlorothiazide.

Each film-coated tablet contains 20 mg of olmesartan medoxomilo and 25 mg of hydrochlorothiazide.

• The other components are monohydrate lactose, microcrystalline cellulose (E460i), low-substituted hydroxypropylcellulose (E463), hydroxypropylcellulose (E463), stearic acid (E570), magnesium stearate (E470b), and Instacoat Universal Pink A05R01291 composed of: hypromellose (E464), polyethylene glycol (E1521), talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the medicinal product and contents of the pack

Olmesartan/Hydrochlorothiazide Combix 20 mg/25 mg is presented as pink, round, biconvex film-coated tablets with bevelled edges, smooth on both sides.

The tablets are supplied in Alu/Alu blister packs with desiccant.

The following pack sizes are available: 28 tablets.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

Zac Les Hautes Pâturages

Parc d'Activités des Pleupliers

25 rue des Pleupliers

92000 Nanterre

France

or

Netpharmalab Consulting Services

Crta. De Fuencarral, 22

28108 Alcobendas (Madrid)

Spain

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/